Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6), CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Imprimis NJOF LLC
OPHTHALMIC
PRESCRIPTION DRUG
unapproved drug other
MYDRIATIC-3- TROPICAMIDE - CYCLOPENTOLATE - PHENYLEPHRINE SOLUTION/ DROPS IMPRIMIS NJOF LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- STORE AT 20° TO 25° C (68° TO 77° F) MYDRIATIC-3 tropicamide - cyclopentolate - phenylephrine solution/ drops PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:7138 4-6 31 ROUTE OF ADMINISTRATION OPHTHALMIC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH TRO PICAMIDE (UNII: N0 A3Z5XTC6 ) (TROPICAMIDE - UNII:N0 A3Z5XTC6 ) TROPICAMIDE 10 mg in 1 mL CYCLO PENTO LATE HYDRO CHLO RIDE (UNII: 736 I6 9 71TE) (CYCLOPENTOLATE - UNII:I76 F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE 10 mg in 1 mL PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - UNII:1WS29 7W6 MV) PHENYLEPHRINE HYDROCHLORIDE 25 mg in 1 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7138 4-6 31- 0 5 5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 1/20 18 Imprimis NJOF LLC MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved drug o ther 0 5/0 1/20 18 LABELER - Imprimis NJOF LLC (080431967) Revised: 5/2018 Baca dokumen lengkap